Biocon TREAT-PLAQ Study (BIOCON)

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Coordinating Center
Emmes India
Emmes U.S.
Project Status
Active
Project Lifespan
09/30/2009
Objective

The T1h mAb TREATment for PLAQue Psoriasis (TREAT-PLAQ) is a multi-center, phase III, randomized double blind, placebo controlled trial designed to determine the efficacy and safety of T1h mAb in subjects with active moderate to severe chronic plaque psoriasis, and to assess whether treatment with T1h mAb therapy improves a patient's quality of life.

The primary objective of this phase III study is to determine the efficacy and safety of T1h mAb in subjects with active moderate to severe chronic plaque psoriasis.

The secondary objective of the study is to assess the effect of T1h mAb therapy on the improvement of quality of life of subjects with moderate to severe chronic plaque psoriasis.

Population

People in India with moderate to severe chronic psoriasis.

Phase
III
Centers

Approximately 20 centers across India

Products
AdvantageEDC
Services
Data Analysis and Reporting
Statistical Leadership and Project Management
Training and Certification
Web-based Data Collection and Reporting Systems
Autoimmune Disease